Kornimate/medical-research-clean huggingface dataset:
follow-up study for men diagnosed with prostate cancer through participation in a prostate specific antigen screening program

Conditions: Prostate Cancer

Summary: there is controversy concerning the preferred treatment for men with localized prostate cancer with regard to the relative effectiveness of different treatments in controlling the cancer and how different treatments affect the patient's quality of life. the purpose of this research is to describe the disease course of prostate cancer and to determine the effectiveness, potential complications, and quality of life after different treatments in men with prostate cancer detected via screening with prostate-specific antigen (psa) and/or digital rectal examination


Eligibility criteria:
men with prostate cancer diagnosed through the psa screening study
7.0 tesla resonance magnetic imaging of the hand in systemic sclerosis

Conditions: Systemic Sclerosis; 7.0 Tesla Magnetic Resonance Imaging; Hand Vascular Involvement; Hand Osteoarticular Involvement

Summary: systemic sclerosis (ssc) is a rare systemic autoimmune disease with specific osteoarticular pattern of unknown mechanism. ischemic phenomenon have been suggested to participate to the osteoarticular involvement in ssc. to date, osteoarticular pattern and hand vascular involvement have been few studied in magnetic resonance imaging in ssc, and most often with low resolution rmi. 7 tesla rmi allows high resolution for morphology examination, together with dynamic and functional vascular study and sodium articular concentration. indeed, the aim of the study is to describe hand osteoarticular and vascular involvement in ssc, as well as sodium articular concentration. clinico-biological association will be also assessed.


Eligibility criteria:
inclusion criteria: * patients with ssc: - scs fulfilling acr/eular 2013 classification criteria and followed in the department of internal medicine of poitiers university hospital, without clinical signs of digital arthrose * control subjects: - hospitalized patients in the department of internal medicine of poitiers university hospital, without raynaud's phenomenon, neither antecedent of inflammatory rheumatism and/or autoimmune disease, neither inflammatory articular symptoms during the previous month and no clinical signs of arthoses and/or arthritis at the inclusion in the study * for both: * age ≥ 18 years-old * written informatory consent exclusion criteria: * patients with ssc: - ssc associated with other define autoimmune disease (overlap syndrome) * for both: * absolute contraindication to 7.0 t rmi: pregnancy; ocular metallic foreign body ; cardiac pacemaker ; neurostimulator no compatible 7.0 t rmi ; cochlear implants; all electronic medical device implantedfor less than 6 weeks ; metallic heart valve ; old cranial vascular clips * individuals with current health condition not allowing realization of the 7.0 t rmi in sufficient comfort conditions according to investigator appreciation (i.e. acute cardiac and/or respiratory failure, impossibility to maintain procubitus, bedridden individuals, claustrophobia) * individuals under tutorship or guardianship * individuals with reinforced protection: minors, judiciary or administrative decision * no affiliation to social insurance * pregnancy or breastfeeding
comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia

Conditions: Acute Lymphoblastic Leukemia

Summary: this multicentric phase iii study is designed to assess the efficacy and safety of recombinant asparaginase (rasnase) in comparison to asparaginase medac™ during treatment of children with de novo all


Eligibility criteria:
inclusion criteria: * previously untreated t-lineage or precursor b-lineage all * patients must have morphological proof of all and diagnosis must be made from bone marrow morphology with more than 25% blasts * written informed consent * treatment according to dcog all 10 protocol exclusion criteria: * mature b-lineage all * patients with secondary all * known allergy to any asnase preparation * general health status according to karnofsky / lansky score \< 40% * pre-existing known coagulopathy (e.g. haemophilia) * pre-existing pancreatitis * liver insufficiency (bilirubin \> 50 µmol/l; sgot/sgpt \> 10 x uln) * other current malignancies * pregnancy (planned or existent), breast feeding

Keywords: children with previously untreated acute lymphoblastic leukemia
adipose tissue in crohn´s disease fistulas

Conditions: Crohn Disease; Perianal Fistula; Tissue Transplantation

Summary: present study investigated the efficacy of injection of freshly collected autologous adipose tissue into perianal fistulas in patients with crohn's disease. adipose tissue collected by liposuction was injected into the perianal fistulas. primary objective was complete clinical healing six months after treatment. secondary objectives were reduced or ceased fistula secretion and complications to the treatment.

investigators prospectively registered symptoms, complications and results of treatment in 21 patients with crohn´s disease who underwent treatment with freshly harvested autologous adipose tissue for perianal fistulas between march 2015 and june 2018. inclusion criteria consisted of the following: the presence of complex cd fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment. pelvic magnetic resonance imaging (mri) was performed to describe the location and extent of the fistula. clinical examinations of the patients were performed at intervals of six weeks, three months and six months following adipose tissue injection. primary endpoint was complete fistula healing at clinical examination six months after the last injection. a fistula was considered completely clinically healed: (i) if the patient had no symptoms of discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii) if no internal opening could be palpated with rectal digital examination. secondary endpoints included either reduced or ceased fistula secretion. if clinical healing of the fistula was not obtained six weeks after the first treatment, patients were offered a second adipose injection within two weeks. a third injection was offered to patients who did not have complete healing within six weeks of the first two injections.pelvic mri was repeated in all patients with transsphincteric and intersphincteric fistulas who, upon clinical examination, demonstrated complete healing at 6 months after the last injection.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of crohn´s disease * presence of complex crohn´s disease fistulas * fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment. exclusion criteria: - fistulas developed following proctectomy were excluded.
an observational study of lymphoma in patients with rheumatoid arthritis or crohn's disease.

Conditions: Lymphoma

Summary: the purpose of this study is to examine the association with ebv infection, monitor the occurrence of lymphoma and assess lymphoma risk in patients with rheumatoid arthritis and/or crohns disease and you have taken infliximab.

this is an observational (review of records), retrospective (research activity that is performed after the events under the study have occurred), registry study where data was collected from 3 different registries sponsored or supported by centocor. registries are centocor-sponsored therapy resource evaluation and assessment tool (treat™) registry of crohn's disease, and in the following two centocor-supported registries the consortium of rheumatology researchers of north america, inc. (corrona) registry and the infliximab ra registry, a subset of the national database registry of rheumatoid arthritis (ndbrra) and of the national databank for rheumatic diseases (ndb). a registry is data collection in a real life physician-patient setting. physicians prescribe medications for rheumatoid arthritis and/or crohns disease in accordance with their usual clinical practice and then record this information and provide it to centocor. for this registry study, centocor collected data from 3 registries to evaluate the risk of getting lymphoma if you have rheumatoid arthritis and/or crohns disease and you have taken infliximab. patients who were in one of the 3 registries and had rheumatoid arthritis and/or crohns disease and did not take infliximab were also evaluated. this registry study does not involve the use of any investigational drugs.

Eligibility criteria:
inclusion criteria: * patients with crohns disease or rheumatoid arthritis who participate in the specified registries will be included in the analysis. for the lymphoma analysis, patients must be recorded as having a lymphoma during their participation in one of these registries exclusion criteria: * patients who do not have crohns disease or rheumatoid arthritis and who did not participate in one of the identified registries will be excluded from the study

Keywords: lymphoma rheumatoid arthritis crohn's disease remicade infliximab
obalon balloon system post-approval study

Conditions: Obesity

Summary: the obalon balloon system - post-approval study is a prospective, observational, and multi-center study.

the obalon pas is a 1-year study that includes 6-month of obalon balloon therapy in conjunction of a weight loss behavior modification (wlbm) program and 6-month of continued wlbm program after balloon removal

Eligibility criteria:
inclusion criteria: * at least 22 years old * bmi of 30-40 kg/m2 exclusion criteria: * contraindicated for the device * use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months. * known history of endocrine disorders affecting weight. * participation in any clinical study which could affect weight loss within the past year * known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus * life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator
the effect of statin treatment on arterial wall inflammation as assessed with 68ga-dotatate pet-ct

Conditions: Diabetes Mellitus, Type 2; Vascular Inflammation

Summary: to study the effect of atorvastatin treatment on vascular uptake of 68ga-dotatate in patients with type 2 diabetes.

well controlled patients with type 2 diabetes, who are statin naïve, will undergo atorvastatin treatment. before and after treatment, patients will undergo a 68ga-dotatate pet/ct, to evaluate the effect of treatment on vascular inflammation.

Eligibility criteria:
inclusion criteria: 1. aged 50 years and older 2. diagnosed with diabetes mellitus type 2 and using oral glucose lowering therapy, insulin or combined glucose lowering therapy. 3. not on statin therapy or willing to stop with current statin therapy for 6 weeks prior to visit 2. 4. hba1c values below 65 mmol/l. 5. patients with "stable" diabetes mellitus, i.e. no changes in type of glucose lowering therapy and / or dosage of oral glucose lowering therapy in the past three months. no more than 20% change in dosage of insulin therapy (short and long acting) in the last three months. exclusion criteria: 1. history of cardiovascular disease (previous cv-event (mi / stroke) or known coronary artery disease (including acute coronary syndrome). 2. history of chronic kidney disease stage 3b - 5, defined as a ckd-epi value of \< 45 ml/min/1,73m2 3. malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator. 4. chronic or recent (\< 1 month) infections and/or clinical signs of acute infection. 5. history of auto-immune diseases. 6. standard contra-indications to 68ga-dotatate pet, and ct based on physicians experience and current practices. 7. inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. 8. planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons. 9. elevated liver enzymes (\> 2 uln of liver transaminases), acute liver failure or known liver disease. 10. prior medium to severe statin-related side effects or statin related hypersensitivity, i.e. (severe) muscle pains with and/or without myopathy . 11. the concomitant use of statin contra-indicated drugs, including the use of cyp3a4 inhibitors (i.e. erytromycin, dilthiazem, amiodaron, verapamil, fluconazole, ciclosporin, stiripentol, itraconazol, ketoconazol, voriconazol, posaconazol, clarithromycin, ..), systemic use of fusidic acid and ciclosporin. 12. any contra-indications to the use of statins.

Keywords: statin dotatate vascular inflammation type 2 diabetes mellitus pet/ct positron emmission tomography
obstetric anesthesia experiences in covid-19 positive patients

Conditions: Covid19; Obstetric Anesthesia

Summary: at the end of 2019, a new coronavirus named covid-19 (sars-cov-2), one of the lower respiratory tract samples was detected in china. the world health organization (who) declared it a global epidemic on march 11, 2020, due to the emergence of covid-19 cases in 113 countries other than china, where the first epidemic occurred, and the spread and severity of the virus. pregnancy increases susceptibility to respiratory complications of viral diseases. this study aimed to retrospectively evaluate the demographic data of covid-19 patients undergoing cesarean section, our anesthesia practices, complications, and condition of neonates, and to summarize up-to-date information on covid-19 in obstetric anesthesia.

our study was a single-center, retrospective, and observational trial and carried out with the principles of the declaration of helsinki. all patient demographics and information about anesthesia were analyzed retrospectively from the patient files. all patients were operated in negative pressure operating theatres reserved for them. the whole team was equipped with level 3 personal protective equipment (ppe) (liquid-proof apron, n-95 mask, goggles, visor, overshoes). anesthesia was administered by 2 healthcare professionals from the anesthesia team, including an experienced anesthesiologist and an assistant anesthesia technician. a third person was kept ready outside to help in case of need.

Eligibility criteria:
inclusion criteria: * patients who underwent cesarean section * patients who had positive pcr nasopharyngeal swabs for covid-19 exclusion criteria: * patients who tested negative and were clinically suspicious

Keywords: covid-19 anesthesia cesarean section pneumonia
plasma concentration of biological markers in placenta accreta spectrum

Conditions: Placenta Accreta; Placenta Diseases

Summary: the purpose of this exploratory study is to determine how well maternal serum biomarkers and placental micro-particles (mp) correlate with placenta accreta spectrum (pas) at the time of cesarean delivery in women with suspected pas compared to women without pas. our aim is to determine if women with pas have a unique mp and protein signature at the time of delivery compared with women without pas.

maternal blood samples will be taken at various points during the intrapartum period. a healthy group of women admitted for delivery will act as a matched control and will have their blood sampled at similar time points. the primary outcome variables will include the total number of micro-particles, the number of micro-particles from each cell line (platelet, placental, endothelial etc.), and protein markers the knowledge gained from this study has the potential to develop a diagnostic test for pas with the ability to improve management and outcomes for mother and baby through earlier diagnosis.

Eligibility criteria:
inclusion criteria: * age 18 - to 45-years old, inclusive * suspected or confirmed pas or phenotypically matched controls * delivery by cesarean section * gestational age greater than 28 weeks * singleton pregnancy exclusion criteria: * intrauterine fetal demise, * severe fetal anomalies (infant not expected to survive) * emergent cesarean delivery
efficacy of targeted medical therapy in angina and nonobstructive coronary arteries

Conditions: Angina Pectoris; Microvascular Angina; Vasospastic Angina; Myocardial Bridge of Coronary Artery

Summary: the goal of this clinical trial is to learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing. participants will be treated with either medications that target the underlying cause of their chest pain or placebo for 4 weeks after a drug titration phase of 1-3 weeks. they will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.


Eligibility criteria:
inclusion criteria: * all patients with stable angina referred to the stanford university hospital cardiac catheterization laboratory for clinically indicated coronary function testing are eligible for inclusion into the study. specific inclusion criteria for randomization: * absence of significant epicardial coronary artery disease on angiography * fractional flow reserve \> 0.80 and ≥ 1 of the following: * epicardial coronary spasm on acetylcholine testing * microvascular spasm on acetylcholine testing * coronary flow reserve \< 2.5 * index of microcirculatory resistance ≥ 25 * myocardial bridge on intravascular ultrasound with dobutamine resting full-cycle ratio ≤ 0.76 exclusion criteria: * acute coronary syndrome less than one week prior to enrolment * cardiomyopathy * contraindications to beta-blockers or calcium channel blockers * baseline systolic blood pressure \< 95 mmhg * baseline heart rate \< 55 bpm
multiple dose trial of anti-glycation agent gly-230 in healthy and diabetic subjects

Conditions: Diabetic Nephropathy

Summary: a dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of gly-230 in healthy and diabetic subjects


Eligibility criteria:
inclusion criteria: * nondiabetic and diabetic men age 18-55, engative drug screen, normal ekg, clinical chemistries. hematology parameters, hba1c 7.5% if diabetic, give written informed consent exclusion criteria: * sctive concomitant serious medical or surgical disease
trial on the efficacy of tegaderm chlorhexidine gluconate (chg) in reducing catheter related bloodstream infections

Conditions: Catheterization; Infection

Summary: tegachg is a multicentric randomized study aimed at evaluating the possibility that the use of tegaderm chg dressing may reduce the incidence of catheter related blood stream infections (crbsi). it implies the comparison between the incidence of crbsi in patients with central venous catheter dressed with tegaderm without chlorhexidine gluconate (chg) and with chg. the primary endpoint is the occurrence of crbsi and the secondary endpoints are: catheter colonization (growth of microbes from the culture of catheter tip, \> 15 cfu according to semi-quantitative method or \> 1000 cfu according to quantitative method); incidence of catheter exit site infection; occurrence of catheter related infections/sepsis or other severe infection-related complications; safety profile evaluation: occurrence of hypersensitivity to the dressing on the basis of local objectivity (erythema, edema, other) or on that of patient symptoms (itch, burning sensation); relating to the device performance: incidence of high/medium/low dressing edge lift, ability to visualize the catheter insertion site, easiness of removal, easiness of dressing application; incidence of unscheduled dressing change. the study hypothesis implies that the use of slow release device containing chlorhexidine may decrease the incidence of crbsi. this has already been showed for chlorhexidine impregnated sponges. scope of the study is to verify if this property is also true for tegaderm chg,which is a new chlorhexidine-releasing dressing in which the medication is directly released by an integrated transparent gel pad, so that the catheter exit site remains visible and easy to inspect without removing the dressing.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hospitalized patients, either in intensive care unit or in non-intensive care ward settings * clinical indication for the insertion of a non-tunneled central venous catheter (excluding large bore catheters for dialysis or pheresis) or a picc exclusion criteria: * age \< 18 years * inability to obtain an informed consent * actual evidence - or recent history (\< 30 days) - of bloodstream infection * central lines inserted in the femoral vein * central lines inserted by surgical cutdown * use of so called 'treated' catheters, i.e. catheters whose internal and/or external surface is coated with antibacterial drugs as well as catheters whose polyurethane releases ions with potential antiseptic action, should be excluded by the present protocol * specific intolerance or known hypersensitivity to transparent dressings or to chlorhexidine * any form of dermatitis, burns, skin lesions or tattoos at the insertion site * burns over ≥ 15% of the body surface area * use of topical antibiotics within a 10cm of the catheter insertion site * enrollment in another investigational drug or device study at any time during this study or 30 days prior.

Keywords: catheter-related bloodstream infections chlorhexidine transparent dressings
robot-assisted vs vats lobectomy for nsclc

Conditions: Pulmonary Neoplasm

Summary: robot-assisted thoracoscopic surgery (rats) was widely used in thoracic surgery, the surgical safety and feasibility of rats lobectomy for nsclc has been confirmed. however, the oncological long-term outcomes of rats lobectomy has not been studied by randomized controlled trial, the purpose of this study is to determine whether rats lobectomy would be as effective as vats lobectomy on short-term and long-term outcomes.

video-assisted thoracoscopic surgery (vats) lobectomy is recommended for non small cell lung cancer (nsclc) with surgical indications in china, its oncological long-term outcomes has been widely approved. as a new form of vats, robot-assisted thoracoscopic surgery (rats) was widely used in thoracic surgery, the 3d vision and flexible robot arm were helpful for surgeons to perform precise operations, and rats was reported to bring extra benefits to patients. the surgical safety and feasibility of rats lobectomy for nsclc has been confirmed. however, the oncological long-term outcomes of rats lobectomy has not been studied by randomized controlled trial. so we designed this randomized controlled trial to determine whether rats lobectomy would be as effective as vats lobectomy on short-term and long-term outcomes.

Eligibility criteria:
inclusion criteria: 1. surgical indication for lobectomy; 2. minimal invasive surgery; 3. asa (american society of anesthesiologists) stage: i-iii; 4. sign the informed consent. - exclusion criteria: 1. benign tumor or nodule; 2. present of other malignancy; 3. preoperative chemotherapy, radiotherapy, targeted therapy. -

Keywords: lobectomy robot-assisted thoracoscopic surgery lung cancer